This invention pertains to both acoustic and non-acoustic cardiography, and in particular to specially configured and embodied forms of compact, acoustic and non-acoustic, task-specific (acoustic or non-acoustic) cardiography devices designed for personal, self-employable, hand-and-finger-manipulable, single-handed cardiography use. These compact devices specially accommodate self-enabled, patient/subject self-taking, for subsequent use, and in wide-ranging locations, such as in home, clinical, and over-the-counter, settings, of cardiography-relevant recordings intended for eventual cardiography-based, cardiovascular diagnosis. As will be described below herein, the proposed devices are structured preferably, though not exclusively, in different, specific hand-and-finger-manipulable handleable versions designed to suit different kinds of single-handed use applications, and to make “user-friendly” and convenient personal use of an appropriately configured and internally structured device in each of the several, different kinds of settings, or environments, just mentioned.
The development of the present invention has taken place, purposefully, in relation to one of the greatest current challenges for medical systems worldwide—the challenge of managing the growing number of patients with heart diseases.
Regarding this important concern, the US alone has many millions of people with what is called heart failure, and currently, over a half million new heart-failure patients are diagnosed each year. Heart failure is only one form of heart disease, but one of the most expensive ones for health care systems. The heart-failure challenge is growing globally with another 60-million, or so, patients outside of the US. About 50% of these other patients are in Asia, and the number in many developing countries is unknown due to the lack of diagnostic means and public information. Heart failure is a disease of the elderly, and it is growing rapidly in all societies with aging populations, and it is an epidemic burden for the health care system in every country.
In this context, major issues that characterize the management challenge arise both from the lack of simple, inexpensive, non-invasive ways to diagnose, evaluate, and monitor treatment for cardiac patients, and from the growing need to evaluate and monitor, effectively and efficiently, such patients as much as possible outside of the hospital/physician's office/clinic.
Both (a) acoustic cardiography, involving the acquiring of both simultaneous ECG and heart-sound information, and (b) non-acoustic cardiography, involving the acquiring only of ECG information, are low cost, non-invasive diagnostic technologies, which enable a fast assessment of a patient's cardiac function. These technologies provide nearly as much insight into heart function as ultrasound technology, and the normally involved, portable cardiography test equipment is relatively easy to use, with results not requiring much training for result interpretation. The typical cardiography test, most often performed in the realm of acoustic (rather than non-acoustic) cardiography involving the acquisition and analysis of both ECG and heart-sound data, (1) typically, during an optionally-timed, 10-second interval, collects simultaneously generated ECG and heart-sound data, (2) automatically analyses such collected data, and (3) provides interpretive and actionable diagnostic results. Prior-art equipment employed normally for such a test, though most often somewhat involved, can usually be set up relatively quickly, and test-produced results can usually be interpreted by non-expert clinicians. In this setting, state-of-the art cardiography implementations, described here a bit more specifically, currently concentrate, predominantly, on standard ECG instrumentation, and typically use relatively involved equipment models (i.e. Cardiograph, Patient Monitor, Holter), which require specific placements of electrodes on a patient's torso, and multi-wire connections to the employed data-acquisition system.
All in all, a cardiography test is, generally speaking, a good fit with the need to simplify medical diagnostics, to enable preventive cardiac screening in large population settings, and to assist in the management of cardiac patients outside of the above-mentioned hospital/physician's office/clinic setting.
In relation to such state-of-the art practice, the present invention greatly simplifies the performing of cardiography (a) through basing its implementation on the provision of extremely uncomplicated, straightforward, lightweight, highly maneuverable and single-handedly personally usable cardiography devices, and, in this context, (b) through enabling cardiography practice in a multitude of convenient settings, such as in over-the-counter store facilities, in at-home environments, and in simple and unimposing clinical spaces.
As will be seen from what is described hereinbelow, and which will certainly be well-appreciated by those skilled in the relevant art, and notwithstanding the already not too complicated world of cardiography, what is proposed by the present invention, in relation to what has heretofore been available and practiceable in the cardiography-testing world, offers considerably more simplified, and enhanced-user-friendliness equipment, and greatly improved convenience in respect of where a cardiography test may be performed, how it may be conducted, and that it may confidently and quickly be implemented personally by a subject/patient without the need for an attendant clinician, or other assistant.
With this background in mind, the present invention features, in a form which accommodates at least non-acoustic cardiography, a digitally-manipulable cardiography device employable (including single-handedly employable) by a subject, via hand and finger manipulation, to collect personal cardiography-relevant information—this device including (a) a support structure having an elongate, linear, functionality axis, and (b) a cardiography component assembly supported by this support structure and distributed along the functionality axis, including a pair of operatively associated, functionally exposed, anatomy-coupling electrodes designed to collect subject-specific ECG information, and spaced from one another along the functionality axis in positions that are fixed relative to one another so as to move as an electrode unit with subject manipulation of the device during cardiography use of the device. One of the included electrodes is configured and disposed for operative, electrical anatomical coupling with a finger of the subject during subject use of the device, and the other electrode is configured and disposed for operative, electrical anatomical coupling with a subject-selected non-finger-site surface region on the subject's anatomy during subject use of the device.
The proposed device possesses, importantly, a structural organization that promotes subject use of it during the implementation of cardiography in a manner whereby its functionality axis extends along a line which angularly intersects the subject-selected surface region of the mentioned non-finger anatomical site. Such use is quite distinct, in relation to the matter of operative electrode positioning for the acquiring of ECG data, from conventional ECG electrode-placement use, regarding which, data-gathering electrodes typically are disposed contactively on/over a more-or-less singular, broad, somewhat “planar”, anatomical surface expense in a subject. This significant difference specially accommodates convenient, personal, hand and finger manipulative use of a device of the present to perform self-implemented cardiography.
In relation to acoustic cardiography, the invention proposes a device form which additionally features the incorporation, in the mentioned cardiography component assembly, for functioning in cooperation with the therein included ECG-gathering electrodes, of an acoustic sensor designed for collecting subject-specific acoustic heart-sound information.
Regarding each of the just-above-outlined, non-acoustic and acoustic forms of the invention, and in accordance with preferred, but not limiting, configurational implementations of the invention that are preferably determined by suitable and selectable shaping of the device's included support structure, the proposed cardiography device may (as can be seen in a pair of suggested configurations which are illustrated herein) take on, for examples, either one of two, different, high-utility, overall structural shapes, or configurations, including (1) a stylus-like configuration which looks a bit like, and is designed to be held single-handedly, like a pen or a pencil, and (2) a finger-mountable ring configuration which is removeably mountable, for example, on the outer end of a subject's finger, such as on the outer end of the index finger. These two, suggested configurations, which have been found to offer special utility, are but representative illustrations which may inspire those skilled in the art to propose other kinds of overall device configurations suited to various different use applications and environments.
The devices proposed by the present invention, in all forms, may include, and preferably do include for many applications, internal electronic information-handling structure which is appropriately operatively connected to device-included electrodes, and to any included acoustic sensor, such as an accelerometer or a microphone, for receiving therefrom, and capturing and recording, subject/patient-specific ECG and heart-sound acoustic information, and also for performing at least one of (a) internal diagnostic analysis processing, and (b) outward communication for external diagnostic analysis processing, of such received, captured, and recorded information.
Thus, and as will become apparent, the present invention advances the state of the relevant cardiography art by offering compact, single-handedly manipulable, cardiography devices, structured for personal use in two, selectively different, functional-cardiography styles, enabling, respectively, one of the functionality styles of (a) non-acoustic, and (b) acoustic, cardiography, such use involving, as appropriate to the particular functional-cardiography style to be implemented, the collecting and recording of personal cardiography-relevant data—ECG only in a non-acoustic case, and ECG and heart-sound together in an acoustic case—suitable for subsequent data-analysis processing, and associated cardiovascular diagnosis (which may be performed device-internally). Two, very convenient and easy to use, representative device configurations are proposed, including (1) a stylus pen-like shape, and (2) a finger-mount sandwich-stack shape.
As suggested above, collected-data analysis processing, and associated cardiovascular diagnosis, may be performed either by device-included electronic information-handling structure, or by externally linked apparatus which receives an appropriate transmission—a hand-off—of collected cardiography data. In relation to the matter of external, “hand-off” processing and diagnostic analysis, outward handing-off of captured cardiography data may very easily be communicated outwardly from a device constructed according to the invention either, conventionally, wirelessly, or in some suitably enabled, communicatively “tethered” manner.
All modifications of the invention proposed herein are extremely compact, and very simple and intuitive to use, and they amply respond in important and sophisticated ways to the concerns expressed above regarding the swelling issue of heart-failure management.
These and other features and advantages of, and offered by, the invention will become more fully apparent as the detailed description of it which follows below is read in conjunction with the accompanying drawings.
The various elements and components shown in the drawings, and their relative sizes and positional relationships, are not drawn to scale.